Modeling Kappa Opioid Analgesic Mechanisms in Chronic Orofacial Pain Disorders
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
研究概览
简要总结
Patients with chronic masticatory muscle pain (i.e., pain greater than three months) or patients with burning mouth syndrome participate in this study. The aim of the study is to compare the pain killing effectiveness of nalbuphine, a narcotic pain killer, administered with either placebo or naloxone, a drug used to treat opiate overdose. A second goal is to determine if there are sex differences in these two drug regimens. Drugs will be administered with single-use intranasal spray devices. All participants will receive two sprays (one spray per nostril). One of the two sprays will be nalbuphine (5 mg). The other spray will be naloxone in half the participants and placebo in the other half.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of temporomandibular muscle pain OR
- •Clinical diagnosis of burning mouth syndrome
- •Pain duration: at least 3 months
- •Pain severity: 2 or greater on a 0 - 10 scale
排除标准
- •No adverse reaction to study drugs
- •Not currently using narcotic analgesic drugs
研究组 & 干预措施
TMD 1
干预措施: nalbuphine plus naloxone (Drug)
TMD 2
干预措施: nalbuphine plus placebo (Drug)
BMS 1
干预措施: nalbuphine plus naloxone (Drug)
BMS 2
干预措施: nalbuphine plus placebo (Drug)
结局指标
主要结局
Pain Intensity as Measured on a Visual Analogue Scale (VAS) Ranging From Zero to 100.
时间窗: 20 minute intervals for three hours.
次要结局
未报告次要终点